Innovo Research · 1 day ago
Clinical Research Coordinator
Champaign, IL
Full-time
Onsite
Entry Level
1+ years expInnovo Research is seeking a Clinical Research Coordinator (CRC) who is responsible for reviewing, processing, and managing clinical research data and documents. The CRC will support investigators in executing research studies, collect and maintain study data, and ensure compliance with regulatory requirements.
Hospital & Health Care
Responsibilities
Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness
Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research
Recruit and screen participants for clinical trials and maintain subject screening logs
Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose of the study, procedures, and research process
Maintain source documentation based on protocol requirements
Schedule and execute study visits and perform study procedures
Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab logistics
Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or appropriate medical personnel
Correspond with research subjects and troubleshoot study-related questions or issues
Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards
Assist with study data quality checking and query resolution
Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring, if needed
Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards
Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records
Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies
Assist research site with coverage planning related to staffing and scheduling for research studies
Monitor subject safety and report adverse reactions to appropriate medical personnel
Maintain confidentiality of data and PHI as required
Collaborate with provider offices to carry out research in the most efficient workflow possible
Maintains stock of supplies needed to carry out each study per protocol
Performs other duties and projects as assigned
Qualification
Required
Bachelor's degree in a related field
1-2 years of clinical research experience
Relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training, and experience
Willingness to work in Pulmonary clinical trials
Proficient in the use of Microsoft Office applications
Understanding of medical terminology
Working knowledge of clinical trials
Knowledge and ability to apply GCP/ICH and all applicable FDA regulations and guidelines for human subject protection, drug, and device
In-depth knowledge of departmental, protocol, and study-specific operating procedures, consent forms, and study schedules
Skilled in carrying out required clinical procedures such as phlebotomy and vital signs
Strong written and verbal communication skills including good command of the English language
Skill in applying and modifying professional research principles, methods, and techniques to provide ongoing patient care
Skill in preparing/maintaining records, writing reports, and responding to correspondence
Ability to maintain quality control standards
Ability to react calmly and effectively in all situations
Excellent organizational and problem-solving skills
Effective time management skills with the ability to multi-task and manage competing priorities with exceptional attention to detail
Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients
Practice a high level of integrity, honesty, and in maintaining confidentiality
Preferred
Phlebotomy skills preferred (or willingness to learn)
Company
Innovo Research
Innovo Research is a provider-sponsored, provider-led network of high-performing Accountable Care Organizations (ACOs) that utilize clinical research as part of their population health strategy.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Cerdi Beltre
Chief Operating Officer
Halley Losekamp
Senior Vice President Strategy and Partnerships
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